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Data, Freedom of Information releases and corporate reports
Supplementary information for international regulators on packaging changes and the export of UK medicines.
Patient factsheet to provide information on vaccines and vaccine safety.
The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022.
Resources for pharmacies to achieve Healthy Living Pharmacy (HLP) Level 1 status.
Report on the public health impact of nurses and midwives, dentists, allied health professionals and pharmacists.
Guidance for hospital blood banks on issuing blood components electronically in line with best practice.
Guidance for manufacturers who source their own-branded products from another company.
A pathway summarising the processes pharmaceutical companies should follow when preparing to launch new products in the UK.
Acceptable naming, presentation and packaging of nicotine-containing electronic cigarettes and refill containers.
Key insights of three simulation workshops from the AI Airlock pilot testing programme. You should note that these documents are not formal guidance.
The VDEC clinical evaluation team works to support vaccine and therapeutic development by providing expertise in immunological and functional assays used to support clinical trials (Phase I to IV)
Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home
Industry webinars on the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
Guidance for manufacturers of artificial heart valves. It outlines specific scenarios that should be considered when determining if an incident is reportable.
Guidance covering various aspects of pharmacovigilance for authorised and unauthorised medicinal products (Specials and the Early Access to Medicines Scheme (EAMS)).
New Cosmetic Breast Augmentation Risk Awareness Tool for patients to use when considering cosmetic breast implant surgery.
If pharmacies wish to ‘pack down’ larger packs of a medicinal product, they need to follow these instructions
Guidance for specialists for initiation of valproate in female patients and for annual review and pregnancy testing to support adherence to pregnancy prevention requirements during the pandemic.
Instructions for integrating with the new production MORE platform API.
Our Patient Involvement Strategy sets out how we will engage and involve the public and patients at every step of the regulatory journey.
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